Pharmacovigilance

How to report medicine side effects in Pakistan

Side-effect reports are how regulators learn that a medicine, or a particular batch, is causing harm. Reporting takes a few minutes and can protect thousands of other patients. Here's how to do it well.

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Table of contents8 sections

Quick answer

To report a medicine side effect in Pakistan, tell your doctor or pharmacist, and report it to DRAP's pharmacovigilance system (via the DRAP website or helpline 0800-03727). Include the medicine name, batch number, dose, dates taken, what happened and how you recovered. Patients, caregivers and health professionals can all report. If many people react to the same batch, it may be substandard or fake.

Can report a reaction: Anyone
The detail that matters most: Batch
DRAP helpline: 0800-03727
To make a report: Minutes

When to report

Reactions worth reporting

You don't need to be sure the medicine caused it. Suspicion is enough. Seek medical care first for anything serious; see what to do if you took fake medicine.

Serious reactions

Hospitalisation, breathing difficulty, severe rash, seizures, or anything life-threatening.

Unexpected effects

Reactions not listed in the leaflet, or much stronger than described.

Medicine not working

Lack of effect (e.g. antibiotic, antiepileptic) can signal a substandard or fake batch.

New batch, new problem

A medicine that worked before causes problems after switching to a new pack.

Children & pregnancy

Any reaction in a child, or during pregnancy or breastfeeding.

Vaccines & injections

Unusual reactions after injections or vaccination. See fake flu vaccines.

Step by step

How to make a useful side-effect report

1
Get medical help first
For serious symptoms go to a doctor or emergency department and take the medicine pack with you.
2
Keep the pack
Keep the carton, strips and leaflet. The batch number lets regulators check whether others are affected.
3
Write down the details
Medicine, strength, batch, dose, start/stop dates, other medicines taken, what happened and when, and the outcome.
4
Report it
Tell your doctor or pharmacist and report to DRAP via its website or 0800-03727. If you suspect a fake, also report it as a fake.

Doctor and patient discussing a medicine

How side-effect reports uncover fake medicines

A single unusual reaction is hard to interpret. But when several reports point to the same product and the same batch, regulators can sample and lab-test it. Some of the most dangerous counterfeits worldwide were found this way: clusters of treatment failure or unexpected toxicity traced back to one batch.

That's why the batch number is the single most valuable detail in your report. Before reporting, also run it through our batch alert check: it may already be flagged.

What is pharmacovigilance?

Pharmacovigilance is the science of detecting, assessing and preventing medicine side effects. Every country's regulator runs a system that collects reports from patients and health professionals, analyses them for patterns, and acts: updating leaflets, restricting use, or withdrawing products.

DRAP runs Pakistan's national pharmacovigilance programme and shares data with WHO's global database. Your report, even about a well-known side effect, adds to that picture.

Side effect, fake or quality problem?

Different situations, slightly different actions. When unsure, report anyway.

What you notice	Could be	Do this
Known side effect, mild	Normal side effect	Tell your doctor/pharmacist; report if bothersome
Serious or unexpected reaction	Adverse drug reaction	Medical help first, then report to DRAP
Medicine suddenly not working	Substandard or fake batch	Check batch, report
Pack looks wrong too	Counterfeit	Report a fake
Reaction after heat exposure	Storage damage	See storage temperatures

Important

Don't stop essential medicines on your own

If you suspect a side effect from a medicine for a long-term condition, contact your doctor promptly rather than stopping abruptly. They can adjust the dose or switch to another product safely.

Frequently asked questions

Direct answers about report side effects Pakistan.

How do I report a side effect in Pakistan?

Tell your doctor or pharmacist and report to DRAP's pharmacovigilance system through the DRAP website or the helpline 0800-03727.

Can patients report side effects directly?

Yes. Patients and caregivers can report, not only health professionals.

What information should a side-effect report include?

Medicine name, strength, batch number, dose, dates, what happened, other medicines and the outcome.

Will reporting a side effect get a medicine banned?

Not by itself. Reports are analysed for patterns; action follows when evidence supports it. See also: Report a fake medicine.

Is lack of effect worth reporting?

Yes. A medicine that doesn't work can indicate a substandard or counterfeit batch.

Sources & references

Updated 11 November 2026. DrugTrace.pk is independent and not affiliated with DRAP.

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